Recall record at a glance
| Official record | Z-1940-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Datascope Corp. |
| Report date | Jul 24, 2019 |
| Recall initiation date | Jun 17, 2019 |
| Quantity | 6,197 |
| Location | Mahwah, NJ, United States |
Official product description
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
Why the product was recalled
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Distribution information
Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY , RUSSIA , BELGIUM , JAPAN , SAUDI ARABIA , BOLIVIA , JORDAN , SERBIA , BOSNIA AND HERZEGOVINA , KAZAKHSTAN , SINGAPORE , BRAZIL , KENYA , SLOVAKIA , BRUNEI , KOSOVO , SLOVENIA , BULGARIA , KUWAIT , SOUTH AFRICA , CAMBODIA , LATVIA , SOUTH KOREA , CANADA , LEBANON , SPAIN , CHILE , LIBYA , SRI LANKA , CHINA , LITHUANIA , SWEDEN , COLOMBIA , LUXEMBOURG , SWITZERLAND , COSTA RICA , MACAU , SYRIA , CROATIA , MACEDONIA , TAIWAN , CYPRUS , MALAYSIA , TANZANIA , CZECH REPUBLIC , MALDIVES , THAILAND , DENMARK , MALTA , TRINIDAD , DOMINICAN REP , MARTINIQUE , TUNISIA , ECUADOR , MAURITIUS , TURKEY , EGYPT , MEXICO , TURKMENISTAN , EL SALVADOR , MOROCCO , UGANDA , ESTONIA , MYANMAR , UKRAINE , FINLAND , NAMIBIA , UNITED ARAB EMIRATES , FRANCE , NEPAL , UNITED KINGDOM , GEORGIA , NETHERLANDS , URUGUAY , GERMANY , NEW ZEALAND , UZBEKISTAN , GHANA , NIGERIA , VENEZUELA , GREECE , NORTH KOREA , VIETNAM , GUATEMALA , NORWAY , YEMEN , GUYANA , OMAN , ZAMBIA , HONDURAS , PAKISTAN , HONG KONG , and PALESTINE.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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